Clinical Trials, Phase II as Topic - Statistics & numerical data
Research News and Information

Monday, November 23, 2009

On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies.

30 Jul 2009 Drug-independent models that link biomarker response to clinical end points are critical to support early (end of phase II) clinical decisions. In oncology, change in tumor size (a biomarker of drug effect evaluated in phase II) is linked to ... Read more...

Mixtures of prior distributions for predictive Bayesian sample size calculations in clinical trials.

28 Jul 2009 In this paper we propose a predictive Bayesian approach to sample size determination (SSD) and re-estimation in clinical trials, in the presence of multiple sources of prior information. The method we suggest is based on the use of mixtures of prior ... Read more...

Multiple Histology Phase II Trials.

21 Jun 2009 PURPOSE: Testing agents in cancers with multiple disease subtypes, in which the activity of a new treatment may vary between subtypes, presents statistical and logistical challenges. We propose a flexible phase II strategy which includes both ... Read more...

Latest indexed articles for 'Clinical Trials, Phase II as Topic - Statistics & numerical data'

These are the very latest articles for this heading:

• On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies. 30 Jul 2009
• Mixtures of prior distributions for predictive Bayesian sample size calculations in clinical trials. 28 Jul 2009
• Multiple Histology Phase II Trials. 21 Jun 2009
• Pentostatin treatment combinations in chronic lymphocytic leukemia. 30 May 2009
• Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. 29 Apr 2009
• Bayesian decision sequential analysis with survival endpoint in phase II clinical trials. 28 Apr 2009
• MicroRNAs 15a and 16 regulate tumor proliferation in multiple myeloma. 26 Apr 2009
• Clonal expansion of T/NK-cells during tyrosine kinase inhibitor dasatinib therapy. 17 Mar 2009
• Dose selection in seamless phase II/III clinical trials based on efficacy and safety. 13 Mar 2009
• Current issues in oncology drug development, with a focus on Phase II trials. 30 Dec 2008
• Selecting promising treatments in randomized Phase II cancer trials with an active control. 30 Dec 2008
• Between-arm comparisons in randomized Phase II trials. 30 Dec 2008
• Design of Phase II cancer trials for evaluation of cytostatic/cytotoxic agents. 30 Dec 2008
• Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions. 30 Dec 2008
• Curtailed two-stage designs in Phase II clinical trials. 18 Dec 2008
• A group-sequential design for clinical trials with treatment selection. 18 Dec 2008
• Approaches to handling data when a phase II trial deviates from the pre-specified Simon's two-stage design. 18 Dec 2008
• [Rivaroxaban (Xarelto): efficacy and safety] 29 Nov 2008
• [Maraviroc efficacy in clinical studies on the development of the molecule] 29 Sep 2008
• [Resistance to darunavir] 29 Sep 2008

See a longer list of these articles.

Technical information about 'Clinical Trials, Phase II as Topic'

Definition: Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.

Descriptor UI: D017322

Alternative terms: Clinical Trials, Phase II as Topic; Drug Evaluation, FDA Phase II as Topic; Drug Evaluation, FDA Phase 2 as Topic; Evaluation Studies, FDA Phase II as Topic; Evaluation Studies, FDA Phase 2 as Topic;

Allowable Qualifiers: adverse effects; classification; economics; history; instrumentation; methods; mortality; nursing; psychology; standards; trends; utilization; veterinary; statistics & numerical data; contraindications; ethics; legislation & jurisprudence;

Tree Number: E05.318.760.535.210; E05.337.250.210; N05.715.360.775.235.210; N06.850.520.450.535.210;

History Note: 2008(1993)

Technical Notes: for general design, methodology, economics, etc. of phase II clinical trials; a different heading CLINICAL TRIAL, PHASE II is used for reports of a specific phase II clinical trial